Approval for the lap-band. Adjustable gastric banding (lagb. ) system. The device is indicated for use in weight reduction for severely obese patients with a body mass index (bmi) of at least 40 or a bmi of at least 35 with one or more severe comorbid conditions, or those who are 100 lbs. Or more over their estimated ideal weight according to the 1983 metropolitan life insurance tables (use the midpoint for medium frame). It is indicated for use only in severely obese adult patients who have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs. Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives.
| Device | LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM |
| Classification Name | Implant, Intragastric For Morbid Obesity |
| Generic Name | Implant, Intragastric For Morbid Obesity |
| Applicant | ReShape Lifesciences, Inc. |
| Date Received | 2000-02-09 |
| Decision Date | 2001-06-05 |
| Notice Date | 2002-06-03 |
| PMA | P000008 |
| Supplement | S |
| Product Code | LTI |
| Docket Number | 02M-0250 |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | ReShape Lifesciences, Inc. 100 Calle Amanecer san Clemente, CA 92672 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P000008 | | Original Filing |
| S047 |
2019-07-24 |
Real-time Process |
| S046 |
2018-12-19 |
30-day Notice |
| S045 |
2018-12-18 |
135 Review Track For 30-day Notice |
| S044 |
2018-09-24 |
30-day Notice |
| S043 |
2018-06-25 |
30-day Notice |
| S042 |
2018-01-16 |
30-day Notice |
| S041 |
2017-12-15 |
30-day Notice |
| S040 |
2017-12-15 |
30-day Notice |
| S039 |
2017-07-05 |
Normal 180 Day Track No User Fee |
| S038 |
2017-02-15 |
30-day Notice |
| S037 |
2016-01-29 |
Normal 180 Day Track No User Fee |
| S036 |
2015-12-21 |
Normal 180 Day Track No User Fee |
| S035 |
2015-10-26 |
Normal 180 Day Track No User Fee |
| S034 |
2015-07-06 |
Normal 180 Day Track No User Fee |
| S033 |
2015-01-29 |
Normal 180 Day Track No User Fee |
| S032 |
2014-10-06 |
Special (immediate Track) |
| S031 |
2013-04-18 |
Normal 180 Day Track No User Fee |
| S030 |
2013-03-05 |
30-day Notice |
| S029 |
2012-09-13 |
Normal 180 Day Track No User Fee |
| S028 |
2012-06-01 |
Normal 180 Day Track |
| S027 |
2012-02-29 |
Normal 180 Day Track |
| S026 |
2011-10-11 |
Real-time Process |
| S025 | | |
| S024 |
2011-07-14 |
Special (immediate Track) |
| S023 |
2011-03-18 |
Normal 180 Day Track No User Fee |
| S022 |
2011-03-18 |
Normal 180 Day Track No User Fee |
| S021 |
2010-10-12 |
30-day Notice |
| S020 |
2010-09-16 |
Special (immediate Track) |
| S019 |
2010-07-02 |
Normal 180 Day Track No User Fee |
| S018 |
2010-05-21 |
Special (immediate Track) |
| S017 |
2010-04-27 |
Panel Track |
| S016 | | |
| S015 | | |
| S014 |
2008-12-18 |
Special (immediate Track) |
| S013 |
2008-04-07 |
135 Review Track For 30-day Notice |
| S012 |
2008-02-28 |
Normal 180 Day Track |
| S011 | | |
| S010 |
2006-10-03 |
Normal 180 Day Track No User Fee |
| S009 |
2005-10-26 |
Normal 180 Day Track |
| S008 |
2005-08-09 |
Normal 180 Day Track |
| S007 | | |
| S006 |
2003-06-05 |
Normal 180 Day Track |
| S005 |
2002-11-21 |
Normal 180 Day Track |
| S004 |
2002-03-14 |
Normal 180 Day Track |
| S003 |
2002-03-13 |
Normal 180 Day Track |
| S002 |
2002-01-24 |
Normal 180 Day Track |
| S001 |
2002-01-11 |
Normal 180 Day Track |
NIH GUDID Devices